1. Field of the Invention
The invention relates to a method of treating obesity, insulin resistance and co-morbidities of these conditions by removing tissue from the abdomen. More specifically, it relates to a method of removing abdominal fat and omentum to which the fat is attached, in order to improve health. The invention includes a device for safely removing this tissue material.
2. Brief Description of the Related Art
The number of obese and morbidly obese people in the US has grown to 70 million in 2006, of which 10 million are morbidly obese (BMI>40). It is expected that this number will grow to 90 million by 2012. Along with direct deleterious effects, obesity also gives rise to other co-morbidities, the most significant being Type II diabetes (24 million in the US, an increase from 12 million 10 years ago), heart and circulatory disease, including peripheral vascular and stroke.
As discussed below, it is believed that there is a direct connection between abdominal fat and type II diabetes. Although obesity and abdominal fat are closely linked, the ratio between abdominal fat and other body fat is a more important indicator of type II diabetes and other morbidities from hormonally-active fat.
Conventional methods for treating obesity include drugs, dieting and surgery. For many patients, short term dietary changes do not result in long term weight loss. This leads many patients to select surgery, especially those patients with significant morbidity related to obesity. In 2004, the Centers for Medicare & Medicaid Services (“CMS” decided to reimburse bariatric surgery. This decision contributed to an already fast-growing rate of obesity surgery: up from 19,000 in 1998 to over 220,000 in 2006. Average reimbursement per case is approximately $25,000, with significant additional expense to treat follow-on issues, such as infection and gastric problems.
Current methods and devices for removing omentum and fat require either open surgery with large incisions or can be done with difficulty using laparoscopic techniques. However, the current procedures require painstaking cauterization of the blood vessels contained within this tissue material and careful excision. Frequently, the procedure is complicated by bleeding in the area of the tissue removal, requiring prolonged hospitalization and/or reoperation. The complications from bleeding limit the procedure to rare occasions and is only performed by particularly skilled surgeons.
Omentectomy (removal of the omentum and fat) is currently reimbursable but not often done. This may be due in part to the complexity and surgical risks inherent in these operations. These are compounded by the need for prolonged general anesthesia and immobility before and after the surgery.
Removing omental fat from the middle of the abdomen is significant in at least two ways: (1) omental fat is a primary contributor to Type II diabetes, and (2) omental fat contributes to coronary artery disease and other co-morbidities of obesity. Even moderately obese patients with larger abdominal girth are at higher risk for comorbidities like hypertension, diabetes and arterial vascular disease. Abdominal fat remains behind even after significant weight loss and continues to add risk to these patients. Only by removing this abdominal fat can these problems be directly addressed. Abdominal fat is the single largest factor in determining insulin resistance and an atherogenic lipid profile. It is believed that removing abdominal fat can reduce both diabetes (due to insulin resistance) and arterial sclerosis (due to lipogenic atheroma). Reducing arterial sclerosis can lead to a reduction of stroke, hypertension and peripheral arterial disease.
It has been found in a number of human studies that the presence of omental fat has a higher correlation with the production of dyslipidemia, hypertension, congestive heart failure and inflammatory response than the usual measures of obesity, such as BMI (Body Mass Index).
This correlation has been established by substantial animal testing, epidemiological studies relating visceral (omental) fat with metabolic, hormonal and vascular disorders, and with Type II diabetes. There are a number of studies currently underway, but the largest study compared bariatric surgery (Lap Band) with bariatric surgery and omentum removal (A Thörne, 2002). This study was performed on 50 patients. While all received an adjustable gastric band (AGB) for gastric reduction, half (n=25) additionally had a portion of their fatty omentum removed. The total amount removed was small—only 0.8% of total body fat (which amounts to only about 1 pound for a 300-pound person with a BMI of 40). 2 Despite the relatively small amount of fat removed, the omentectomized patients recorded significant reductions in oral glucose tolerance and insulin sensitivity—2 to 3 times greater than control subjects (P=0.009 to 0.04). The authors concluded:
Omentectomy, when performed together with AGB, has significant positive and long-term effects on the glucose and insulin metabolic profiles in obese subjects (A Thörne, 2002).
Multiple published articles are included in this application and are included here by reference. A Thörne, F Lönnqvist, J Apelman, G Hellers and P Amer. “A pilot study of long-term effects of a novel obesity treatment: omentectomy in connection with adjustable gastric banding.” International Journal of Obesity 26.2 (2002): 193-199; Adams, M. The truth on losing abdominal body fat—forget the diet hype, here's how it really works. 18 Apr. 2005. 24 Sep. 2008 <<http://www.naturalnews.com/z006981.html>>; Brochu, M, Starling, R D, Tchernof, A, Matthews, D E, Garcia-Rubi, E and Poehlman, E T. “Visceral Adipose Tissue Is an Independent Correlate of Glucose Disposal in Older Obese Postmenopausal Women.” The Journal of Clinical Endocrinology & Metabolism (2000): 2378-2384; Brower, B G, Visseren, F L J, Stolk, R P and van der Graaf, Y; “Abdominal Fat and Risk of Coronary Heart Disease in Patients with Peripheral Arterial Disease*.” Obesity (2007): 1623-1630; Cid Pitombol, Eliana P Aranjo, Claudio T De Souza, José C Pareja, Bruno Geloneze and Lício A Velloso. “Amelioration of diet-induced diabetes mellitus by removal of visceral fat.” Journal of Endocrinology (2006): 699-706; C V Ferchak, L F Meneghini. “Obesity, bariatric surgery and type 2 diabetes—a systematic review.” Diabetes Metabolism Research and Reviews (2004): 438-445; Despres, J-P, Lemieux, I, Prud'homme, D. “Treatment of obesity: need to focus on high risk abdominally obese patients.” British Medical Journal (2001): 716-720; Flegal K, Carroll M, Kuczmarski R, et al. “Overweight and obesity in the United States: prevalence and trends, 1960-1994.” Int J Obes Relat Metab Dis. (1998): 39-47; Gabriely, I, Ma, X H, Yang, X M, Atzmon, G, Rajala, M W, Berg, A H, Scherer, P, Rossetti, L and Barzlai, N. “Removal of Visceral Fat Prevents Insulin Resistance and Glucose Intolerance of Aging.” Diabetes (2002): 2951-2958; Gan, S K, Kriketos, A D, Poynten, A M, Furler, S M, Thompson, C H, Kraegen, E W, Campbell, L V and Chisholm, D J. “Insulin Action, Regional Fat, and Myocyte Lipid: Altered Relationships with Increased Adiposity.” Obesity Research (2003): 1295-1305; Gaudet, G., Vohl, M-C, Perron, P, Tremblay, G, Gagne, C, Lesiege, D, Bergeron, J, Moorjani, S, Després, J-P. “Relationships of Abdominal Obesity and Hyperinsulinemia to Angiographically Assessed Coronary Artery Disease in Men With Known Mutations in the LDL Receptor Gene.” Circulation (1998): 871-877; Goldberg, C. “‘Visceral’ fat removal prompts hope.” Boston Globe 17 Apr. 2004: n.p. 13. Gower, B A, Munoz, J, Desmond, R, Hilario-Hailey, T and Jiao, X. “Changes in Intra-abdominal Fat in Early Postmenopausal Women: Effects of Hormone Use.” Obesity Research (2006): 1046-1055; Hamdy, O. “The Role of Adipose Tissue as an Endocrine Gland.” Current Diabetes Reports (2005): 317-319; Janssen, I., Katzmarzyk, P T, Ross, R, Leon, A S, Skinner, J S, Rao, D C, Wilmor, J H, Rankinen, T and Bouchard, C. “Fitness Alters the Associations of BMI and Waist Circumference with Total and Abdominal Fat**.” Obesity Research (2004): 525-537; Kelley, D E and Goodpaster, B H. “Review Article, Skeletal Muscle Trigliceride, an Aspect of Regional Adiposity and Insulin Resistance.” Diabetes Care (2001): 933-941; Lemieux, I, Pascot, A, Couillard, C, Lamarche, B, Tchernof, A, Almeras, N, Bergeron, J, Gaudet, D, Tremblay, G, Prud'homme, D, Nadeau, A and Despres, J-P. “Hypertriglyceridemic Waist: A Marker of the atherogenic metabolic triad (hyperinsulinemia; hyperapoliprotein B; Small, dense LDL) in Men?” Circulation (2000): 79; Mass General Hospital. “Growth Hormone Reduces Abdominal Fat, Cardiovascular Risk in HIV Patients on Antiviral Therapy.” ScienceDaily 6 Aug. 2008: n.p; Moghaddam, E, Vogt, J A and Wolever, T M S. “The Effects of Fat and Protein on Glycemic Responses in Nondiabetic Humans Vary with Waist Circumference, Fasting Plasma Insulin, and Dietary Fiber Intake 1.” American Society for Nutrition (2006): 2506-2511; Norstrom, A, Neovius, M G, Rössner, S and Nordstrom, P. “Postpubertal Development of Total and Abdominal Percentage Body Fat: An 8-Year Longitudinal Study.” Obesity (2008): n.p; O'Connor, K G, et al. “Interrelationships of spontaneous growth hormone axis activity, body fat, and serum lipids in healthy elderly women and men.” Metabolism, Clinical and Experimental (1999): 1424-1431; Pedersen S B, Borglum J D, Schmitz O, Bak J F, Sørensen N S, Richelsen B. “Abdominal obesity is associated with insulin resistance and reduced glycogen synthetase activity in skeletal muscle.” Metabolism (1993): 998-1005; Pitombo, C, Araujo, E P, DeSouza, C T, Parja, J C, Beloneze, B and Velloso, L A. “Amelioration of diet-induced diabetes mellitus by removal of visceral fat.” Journal of Endocrinology (2006): 699-706; Pontiroli A Pizzocri P, Librenti M. “Laparascopic adjustable gastric banding for the treatment of morbid (grade 3) obesity and its metabolic complications: a three-year study.” J. Clin. Endocrinol. Metab. (2002): 3555-3561; Pories W J, Swanson M S, MacDonald K G, et al. “Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus.” Ann Surg (1995): 339-352; Schauer, P R. “Effect of Laparoscopic Roux-En Y Gastric Bypass on Type 2 Diabetes Mellitus.” Annals of Surgery (2003): 467-485; Shi, H, Strader, A D, Woods, S C and Seeley, R J. “The effect of fat removal on glucose tolerance is depot specific in male and female mice.” American Journal of Physiology and Endocrinological Metabolism (2007): 1012-1020; Sjostrom C, Lissner L, Wedel H, et al. “Reduction in incidence of diabetes, hypertension and lipid disturbances after intentional weight loss induced by bariatric surgery: the SOS Intervention.” Obes. Res. (1999): 477-484; Soodini, G R and Hamdy, O. “Obesity and Endothelial Function, Obesity and Nutrition.” Current Opinion in Endocrinology & Diabetes (2004): 186-191; Thörne, A, Lönnqvist, F, Apelman, J, Hellers, G and Amer, P. “A pilot study of long-term effects of a novel obesity treatment: omentectomy in connection with adjustable gastric banding.” International Journal of Obesity (2002): 193-199; Vega, G L, Adams-Huet, B, Peshock, R, Willet, D, Shah, B and Grundy, S M. “Influence of Body Fat Content and Distribution on Variation in Metabolic Risk.” The Journal of Clinical Endocrinology & Metabolism (2006): 4459-4466; Yeager, J A Florence and B F. “Treatment of Type 2 Diabetes Mellitus.” American Family Physician (1999): 2049; and Yeckel, C W, Dziura, J and DiPietro, L. “Abdominal Obesity in Older Women: Potential Role for Disrupted Fatty Acid Reesterification in Insulin Resistance.” Journal of the Clinical Endoctrinology and Metabolism (2008): 1285-1291.
There remains a need to effectively and safely remove large amounts of omentum while addressing the risks associated with highly vascularized hormonally active tissue.